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| Sponsor: | ALTANA Pharma |
|---|---|
| Information provided by: | ALTANA Pharma |
| ClinicalTrials.gov Identifier: | NCT00246909 |
Purpose
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.
Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response of these parameters to treatment. Therefore, a questionnaire to assess GERD symptoms was developed (ReQuest TradeMark). An important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect.
The aim of this study is to determine the minimal clinically important difference (MCID) in patients diagnosed with GERD. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest TradeMark). Endoscopy will be performed at the start of the study. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (8 weeks). During the first treatment week, the patients will receive either pantoprazole (tablet) or placebo once daily in the morning; for the following 7 treatment weeks all patients will receive pantoprazole. The study will provide further data on safety and tolerability of pantoprazole.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux |
Drug: Pantoprazole |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Determination of the Minimal Clinically Important Difference (MCID) of the Patient Orientated Self Assessment Scale ReQuest TradeMark in Patients Suffering From Endoscopically Confirmed Gastroesophageal Reflux Disease (GERD), Grade A-D According to Los Angeles Classification Treated With Pantoprazole 40 mg o.d. or Placebo o.d. Over One Week. |
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2005 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main inclusion criteria:
Main exclusion criteria:
Contacts and Locations
Show 51 Study Locations| Study Chair: | Hartmut Heinze, PhD | Altana Pharma, D-78467 Konstanz, Germany |
More Information
| Responsible Party: | Nycomed, Clinical Trial Operations |
| ClinicalTrials.gov Identifier: | NCT00246909 History of Changes |
| Other Study ID Numbers: | BY1023/M3-340 |
| Study First Received: | October 31, 2005 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Gastroesophageal Reflux Gastroesophageal Reflux Disease Pantoprazole |
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pantoprazole |
Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |